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Study on Subcutaneous Infliximab for Patients with Ulcerative Colitis, Crohn's Disease, or Unclassified Inflammatory Bowel Disease

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called infliximab on patients with certain types of inflammatory bowel diseases, including Ulcerative Colitis, Crohn's Disease, and Inflammatory Bowel Disease Unclassified. The study involves switching patients from an intravenous (IV) form of infliximab, which is administered directly into a vein, to a subcutaneous (SC) form, which is injected under the skin. The purpose of the study is to compare the outcomes of patients receiving subcutaneous infliximab every week with those receiving it every other week, after they have been stabilized on an optimized intravenous schedule.

Participants in the study will have previously been in a state of remission, meaning their disease symptoms were under control, without the use of steroids. The study will observe patients over a period of time to see if they can maintain this remission while using the subcutaneous form of infliximab. The trial will last up to 52 weeks, during which the health and experiences of the participants will be monitored to assess the effectiveness and safety of the subcutaneous treatment.

The study will also look at how many patients remain in remission without needing to adjust their treatment, as well as how many might need to switch back to the intravenous form of infliximab. Additionally, the trial will gather information on patients' satisfaction with the subcutaneous treatment and any side effects they may experience. This research aims to provide valuable insights into the management of these chronic conditions and potentially offer a more convenient treatment option for patients.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must have a confirmed diagnosis of Crohn's disease, ulcerative colitis, or inflammatory bowel disease type unclassified. The patient must be in clinical and biological remission without the use of steroids for at least eight weeks prior to the screening.

    The patient must have been receiving intravenous (IV) infliximab for at least 26 consecutive weeks with a stable dosing schedule for at least 20 weeks.

  2. Step 2

    Initial assessment

    The patient undergoes an initial assessment to confirm clinical and biological remission. This includes checking the rectal bleeding score, stool frequency score, abdominal pain score, and liquid stool frequency score.

    Blood tests are conducted to ensure C-reactive protein (CRP) levels are below 10 mg/L and fecal calprotectin levels are below 250 µg/g.

  3. Step 3

    Switch to subcutaneous infliximab

    The patient switches from intravenous infliximab to subcutaneous infliximab. The subcutaneous administration is done either weekly or every other week, depending on the regimen assigned.

    The objective is to maintain clinical and biological remission without the need for treatment optimization.

  4. Step 4

    Monitoring and follow-up

    The patient is monitored regularly to assess the maintenance of steroid-free clinical and biological remission. This includes evaluations at weeks 8, 24, and 52.

    The patient's experience and satisfaction with the switch to subcutaneous therapy are also assessed during these follow-up visits.

  5. Step 5

    End of study evaluation

    At the end of the study period, the patient's overall health and remission status are evaluated. The primary endpoint is the proportion of patients maintaining remission by week 52 without treatment optimization.

    Secondary endpoints include the proportion of patients maintaining remission with or without treatment optimization and the time to clinical relapse or treatment discontinuation.

Who can join the trial?

9 criteria

  • Patients must have a previously documented diagnosis of **Crohn's disease (CD)**, **Ulcerative colitis (UC)**, or **Inflammatory bowel disease type unclassified (IBDU)**. This diagnosis should be confirmed by medical tests such as clinical exams, endoscopy (a procedure to look inside the digestive tract), histology (study of tissues), or radiology (imaging tests).
  • Both males and females who are **18 years old or older** can participate.
  • Patients must be in **steroid-free clinical remission** at the time of screening. This means they should not have used steroids for the past eight weeks and should have specific scores for symptoms like rectal bleeding and stool frequency for UC/IBDU, or abdominal pain and liquid stool frequency for CD.
  • Patients must be in **biological remission** at screening, which means having a **C-reactive protein (CRP)** level of less than 10 mg/L and a **fecal calprotectin** level of less than 250 µg/g. These are tests that help measure inflammation in the body.
  • Patients should have been receiving **intravenous (IV) infliximab** for at least 26 consecutive weeks. Infliximab is a medication used to treat these conditions.
  • Patients should have been on a stable IV dosing schedule for at least 20 weeks.
  • Patients should have received an average IV infliximab dose every eight weeks, based on the two most recent administrations, of more than 8 mg/kg but not more than 22 mg/kg.
  • Patients must be able to speak and read fluently in **Dutch**, **French**, or **English**.
  • Patients must be able to voluntarily give their written informed consent, which means they agree to participate in the study after understanding all the details.

Who cannot join the trial?

4 criteria

  • Patients who are not in **clinical remission**. This means their symptoms are not under control.
  • Patients who are not in **biological remission**. This means their lab tests do not show improvement.
  • Patients who have not been on an **optimized intravenous schedule** before switching to the new treatment. This means they haven't been receiving the previous treatment in the best possible way.
  • Patients who are part of a **vulnerable population**. This refers to groups of people who might need special protection or care.
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Investigated drugs

Infliximab: In this clinical trial, infliximab is being used in a subcutaneous form. Infliximab is a medication that helps reduce inflammation in the body. It is often used to treat conditions like rheumatoid arthritis, Crohn's disease, and ulcerative colitis. The trial is comparing the effects of administering infliximab under the skin every week versus every other week. The goal is to see which schedule is more effective for patients who were already in remission with a previous intravenous treatment.

What is already known about the treatment

Infliximab – This medication is administered subcutaneously, meaning it is injected under the skin. It is currently being studied in clinical trials to determine its effectiveness when switched from an intravenous form to a subcutaneous form for patients in remission. Infliximab is primarily used to treat conditions like ulcerative colitis, inflammatory bowel disease type unclassified, and Crohn's disease. It works by blocking a protein called tumor necrosis factor-alpha (TNF-alpha), which plays a role in causing inflammation in the body. Infliximab is classified as a monoclonal antibody, a type of medication that targets specific proteins in the immune system to reduce inflammation.

Investigated diseases

  • Ulcerative Colitis

    Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by continuous inflammation of the innermost lining of the colon, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. The disease often progresses with periods of flare-ups and remissions. Over time, the inflammation can cause ulcers to form on the colon lining, which may lead to complications if not managed properly.

  • Inflammatory Bowel Disease Type Unclassified

    Inflammatory bowel disease type unclassified (IBDU) is a condition where the symptoms and inflammation in the digestive tract do not clearly fit the criteria for either Crohn's disease or ulcerative colitis. Patients with IBDU experience symptoms such as abdominal pain, diarrhea, and fatigue. The disease progression can vary, with some individuals experiencing mild symptoms and others having more severe episodes. The inflammation can affect different parts of the digestive tract, making it challenging to categorize.

  • Crohn's Disease

    Crohn's disease is a chronic inflammatory condition that can affect any part of the gastrointestinal tract, from the mouth to the anus. It is characterized by patchy areas of inflammation, which can penetrate deep into the layers of the bowel tissue. Symptoms often include abdominal pain, diarrhea, weight loss, and fatigue. The disease can progress with periods of remission and flare-ups, potentially leading to complications such as strictures or fistulas.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508166-15-00Protocol codeBIRD2023001Estimated enrolment275 patientsSponsorBelgian IBD Research and Development

sourced from the EU Clinical Trials Register and site verification

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